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Prepared Presentations and Discussion

Dr. Patricia Ganz, Professor of Medicine, University of California, Los Angeles: Just over 20 years ago the National Cancer Institute (NCI) issued its first request for application (RFA): Patterns of Care for Elderly Cancer Patients: Implications for Cancer Control, 1983. This RFA was a direct result of the work of our first invited speaker, Rosemary Yancik, who was then at the NCI. Research conducted as part of that RFA demonstrated that older patients received poorer quality of care, even when they did not have comorbid conditions. Furthermore, studies through the NCI’s Cooperative Trials Groups documented consistent underrepresentation of elderly people in clinical trials. Indeed, standards of eligibility specifically excluded people over 65 years of age. Eventually, as discrimination against elderly people became an issue in general, these problems began to be recognized. The Medicare Hospice Benefit did not exist at that time. Rehabilitation primarily involved helping the recovery of patients who had radical surgery (e.g., radical mastectomy, amputation, or laryngectomy). The focus was on inpatient hospitalizations, which in that era were quite prolonged.

Where are we today? Unfortunately, older cancer patients still do not receive standard care, in spite of nearly universal health insurance for that population through Medicare. Older cancer patients continue to be underrepresented in clinical trials. Hospice care is covered by the Centers for Medicare and Medicaid Services (CMS), but referral often occurs very late in the course of illness, possibly because of patient or physician reluc-



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Cancer in Elderly People: Workshop Proceedings 2 Prepared Presentations and Discussion Dr. Patricia Ganz, Professor of Medicine, University of California, Los Angeles: Just over 20 years ago the National Cancer Institute (NCI) issued its first request for application (RFA): Patterns of Care for Elderly Cancer Patients: Implications for Cancer Control, 1983. This RFA was a direct result of the work of our first invited speaker, Rosemary Yancik, who was then at the NCI. Research conducted as part of that RFA demonstrated that older patients received poorer quality of care, even when they did not have comorbid conditions. Furthermore, studies through the NCI’s Cooperative Trials Groups documented consistent underrepresentation of elderly people in clinical trials. Indeed, standards of eligibility specifically excluded people over 65 years of age. Eventually, as discrimination against elderly people became an issue in general, these problems began to be recognized. The Medicare Hospice Benefit did not exist at that time. Rehabilitation primarily involved helping the recovery of patients who had radical surgery (e.g., radical mastectomy, amputation, or laryngectomy). The focus was on inpatient hospitalizations, which in that era were quite prolonged. Where are we today? Unfortunately, older cancer patients still do not receive standard care, in spite of nearly universal health insurance for that population through Medicare. Older cancer patients continue to be underrepresented in clinical trials. Hospice care is covered by the Centers for Medicare and Medicaid Services (CMS), but referral often occurs very late in the course of illness, possibly because of patient or physician reluc-

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Cancer in Elderly People: Workshop Proceedings tance. In contrast to 20 years ago, most cancer care today occurs in the outpatient setting. There has been a dearth of interest in cancer rehabilitation services mostly because reimbursement for outpatients has not been supported. Thus, because of the outpatient locus and complexity of care, there is a high burden on families, particularly if one is a member of the “sandwich generation” (i.e., a person taking care of a parent). Despite this state of affairs, data show there have been gradual improvements in survival of older people with cancer, although these improvements lag far behind those made in pediatric oncology. Sixty percent of survivors are currently over age 65. Even if they were not diagnosed when they were older, they are living into their older years. Breast, prostate, and colon cancers are the three most prevalent cancer sites. Approximately 14 percent of the 10.5 million estimated cancer survivors were diagnosed over 20 years ago. They are often living with complications of treatments that at the time were much more radical and much more toxic than procedures of today. Some final thoughts as we begin our discussion: I think the older cancer patient provides an opportunity for us to think of all the issues that we face in cancer care, including quality of care, access to care, survivorship concerns, and end of life. I am grateful to the leadership and members of the NCPF for encouraging discussion on this topic. I think the speakers today will give us a glimpse of all of these issues in a very important context—our older cancer patient population. Dr. Betty Ferrell, Research Scientist, City of Hope National Medical Center: In the National Cancer Policy Forum (NCPF), we tend to think inclusively about whatever topic we discuss: What are the quality-of-care issues? What are the issues of access, of diversity, and the underserved? What are the problems across the trajectory from diagnoses through end-of-life care? And what is the financial burden on our health-care system and on the individual? I do not think there is any other topic that could be tackled that could cross all of those areas as well as cancer in elderly people. In addition, so often we select a topic and deal with it because it is a current crisis, but addressing cancer in elderly people gives us an opportunity, as Dr. Ganz has shown, to be thinking ahead. If we project 5 or 10 years from now, clearly the demand on our system will be overwhelming. I think we have an opportunity, whatever the outcome of this workshop, to speak to the future and what challenges we will be facing.

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Cancer in Elderly People: Workshop Proceedings Dr. Rosemary Yancik, Health Scientist Administrator, Geriatrics Branch, Geriatrics and Clinical Gerontology Program, National Institute on Aging, National Institutes of Health: The U.S. Demographic Imperative: Implications for Oncology Practice: Why an emphasis on cancer in the older person? According to the NCI Surveillance, Epidemiology, and End Results (SEER) Program data, persons aged 65 and older are at higher risk for most major malignancies. Coupled with this vulnerability, persons in this age group are also likely to have concomitant health problems also associated with advancing age (i.e., comorbidity). In Table 2-1, showing median ages of patients at diagnosis for both sexes, we observe that with the exception of non-Hodgkin’s lymphoma (NHL), the median age in males for these common cancer sites is uniformly above the age of 65, and in some cases the median age is above 70 years. For females the situation is about the same for the tumors common to both men and women, and the total numbers for each sex are similar. In Figure 2-1, the proportion of cancers in all sites in the 65 and older population is 56 percent; for many individual tumors, the proportions rise much higher. TABLE 2-1 Median Age of Cancer Patients at Diagnosis, 2000–2003   Male Female Cancer Site Median Age Number Median Age Number Breast 67 1,720 61 212,920 Colon 71 49,220 75 57,460 Corpus uteri — — 63 41,200 Leukemia 66 20,000 68 15,070 Lung 70 92,700 71 81,770 NHL* 64 30,680 69 28,190 Ovary — — 63 20,180 Pancreas 70 17,150 74 16,580 Prostate 68 230,110 — — Rectum 66 23,580 70 18,350 Stomach 70 13,400 74 8,880 Bladder 72 44,690 74 16,730 Total   523,350   517,330 *NHL = non-Hodgkin’s lymphoma. SOURCE: Adapted by Yancik from ACS Facts and Figures, 2006; NCI SEER Program Data, 2000–2003.

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Cancer in Elderly People: Workshop Proceedings FIGURE 2-1 Proportion of tumors in patients 65 and older. NOTE: Values reflect all races and both sexes. NHL = non-Hodgkin’s lymphoma. SOURCE: Adapted by Yancik from NCI SEER Program Data, 2000–2003. Figure 2-2 shows age-adjusted incidence and death rates for all cancer sites combined. The age-adjusted rate per 100,000 population, 2183.2, is 10 times greater for individuals 65 years and older as compared to 223.7, the rate for younger persons. Figure 2-3 shows the incidence for all sites in males and females. Age adjusted-death rates are 17 times greater for this age comparison with a rate of 64.2 for those ages less than 65 and 1096.4 for those age 65 and older. Figure 2-4 shows the latest SEER data for distribution of deaths at different ages for all-site cancers. Age-specific differences from the NCI SEER Program for selected age groups further reveal distinctions along the aging continuum for males and females, all sites combined. Figure 2-4 illustrates death rates throughout the age-group spectrum and displays the preponderance of the proportion of cancer deaths in the 65 and over population with a further delineation of that population into 65–74, 75–84, and 85 and over. Figures 2-5 and 2-6, constructed from the same data sources for a subset of age groups, display the numbers of deaths for males and females caused by the four top common cancers—lung, colorectal, and either pros-

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Cancer in Elderly People: Workshop Proceedings FIGURE 2-2 Age-adjusted incidence and death rates, all cancers. SOURCE: Adapted by Yancik from NCI SEER Program Data 2000–2003. FIGURE 2-3 All-site cancer incidence rates by age and sex, 2000-2003. SOURCE: Adapted by Yancik from NCI SEER Program Data 2000–2003.

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Cancer in Elderly People: Workshop Proceedings FIGURE 2-4 Age distribution (%) of all-site cancer deaths, 2006. SOURCE: Adapted by Yancik from the National Center for Health Statistics Death Estimates, U.S. Mortality Public Use Tapes, 1975–2003 as analyzed by the NCI SEER Program. FIGURE 2-5 Male deaths for lung, prostate, and colorectal cancer by age, 2000. SOURCE: Adapted by Yancik from NCI SEER Program Data, 2000–2003.

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Cancer in Elderly People: Workshop Proceedings FIGURE 2-6 Female deaths for lung, breast, and colorectal cancer by age, 2000. SOURCE: Adapted by Yancik from NCI SEER Program Data, 2000–2003. tate or breast. The pattern of cancer prominence in older age groups is sustained with these data. Who are the elderly, and what does “old” mean? Table 2-2 displays the life expectancies of Americans throughout the 1900s. In 1900, life expectancy was 46 years, with 11.5 years remaining for men at that age, and, for women, 48 with 12.2 years remaining. Progressing through the decades of the 20th century to the present, U.S. life expectancy is almost twice as high as it was in 1900. This is very important. We are aging within the aged in this country. There are more older persons than ever before in history. More older persons are surviving to the oldest ages, and by 2030 one in five, or 70 million, Americans will be 65 years or older. Figure 2-7 displays how the population age pyramid of 1982 has gradually shifted to an age rectangle because of the aging of the 76 million baby boomers born between 1946 and 1964. In this context, the magnitude of the cancer burden in elderly people clearly requires our urgent attention. The Census Bureau projects the number of older people (those 65 or over) in the United States to reach over 70 million in 2030 with the oldest-old (age 85 years or older) projected to double by 2030 from 4.7 million to 9.6 million.

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Cancer in Elderly People: Workshop Proceedings TABLE 2-2 U.S. Life Expectancy at Birth, 1900–2000 (Years Remaining) Year Men Women 2000 74.1 (16.3) 79.5 (19.2) 1980 70.0 77.4 1960 66.6 73.1 1940 60.8 65.2 1920 53.6 54.6 1900 46.3 (11.5) 48.3 (12.2) SOURCE: Adapted by Yancik from NCHS/U.S. Census Bureau, 2005. FIGURE 2-7 Expanding U.S. aging population. SOURCE Adapted by Yancik from U.S. Census Bureau Current Population Reports P2-1104, 1993. People are aging to older ages because in general they are healthier. The presence of comorbidities and cancer in older patients was mentioned earlier. The remainder of this presentation features data on female breast cancer which, after lung cancer, is the second highest cause of U.S. cancer

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Cancer in Elderly People: Workshop Proceedings deaths in women. According to most recent American Cancer Society data, about 41,000 deaths from breast cancer occurred in 2006. In a National Institute on Aging (NIA)/NCI cancer and comorbidity collaborative study on the comorbidity burden of 1,800 breast cancer patients (using a population-based random sample of patients aged 55 to 101 years), my colleagues and I found that the number of comorbidities ranged from 0 to 13 per patient; the numbers of health problems increased with age (Yancik et al., 2001). With aging, physiological decrements and susceptibility to geriatric syndromes (incontinence and falls, among others) increase, as do chronic disease, susceptibility to infections, and other comorbidities. All of the major diseases and conditions common to older persons (e.g., heart-related conditions, diabetes, hypertension, chronic obstructive pulmonary diseases [COPD], cerebrovascular diseases, urinary tract problem, and subcategories of each were included in the study). Data were collected on the comorbidities of breast cancer patients by retrospective hospital record review. We also categorized by severity. The number of comorbidities for individual patients ranged from 0 to 13. Percentages are shown in Table 2-3: 263 patients (15 percent) died at or before the 30-month follow-up: from breast cancer (51.3 percent), heart disease (17 percent), or previous cancers (8.4 percent). To briefly describe this sample of new breast cancer patients, 73 percent were diagnosed with stage I or II disease, 10 percent with stage III or TABLE 2-3 Cause of Death in Breast Cancer Sample   55–64 65–74 75–84 85+ Total Breast cancer 48 (75.0) 33 (58.9) 38 (44.7) 16 (27.6) 135 (51.3) Other cancers 4 (6.2) 6 (10.7) 9 (10.6) 3 (5.2) 22 (8.4) Heart disease 4 (6.2) 4 (7.1) 18 (21.2) 19 (32.8) 45 (17.1) Cerebrovascular 0 1 (1.8) 4 (13.8) 8 (13.8) 13 (4.0) Digestive 1 (1.6) 1 (1.8) 3 (3.5) 4 (6.9) 9 (3.4) Alzheimer/dementia 1 (1.6) 0 4 (4.7) 2 (3.4) 7 (2.7) Pneumonia 0 0 2 (2.4) 3 (5.2) 5 (1.9) COPD*/respiratory 1 (1.6) 2 (3.6) 1 (1.2) 1 (1.7) 13 (4.9) Other 5 (7.8) 4 (7.1) 2 (2.4) 2 (3.4) 13 (4.9) Unknown 0 5 (8.9) 4 (4.7) 0 9 (3.4) Total deaths 64 56 85 58 263 Total patients 622 624 427 127 1800 *COPD = chronic obstructive pulmonary disease. SOURCE: Adapted from Yancik et al., 2001.

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Cancer in Elderly People: Workshop Proceedings FIGURE 2-8 Frequency of breast cancer patients with one or more severe comorbidities by age. SOURCE: Yancik et al., 2001. IV, and 17 percent were not staged. Patients with stage I and II disease almost always (95 percent) received standard treatment, but patients in older age groups were less likely to receive therapy consistent with the National Institutes of Health (NIH) consensus statement or to have axillary dissections (and staging). Comorbidity, which increases in frequency in older patients, as shown in Figure 2-8, limits the ability to obtain prognostic information, tends to minimize treatment options, and increases the risk of death from causes other than breast cancer as shown for this NIA/ NCI study sample in Table 2-3, which summarizes the cause of death outcomes for this cohort of women with breast cancer. Breast cancer is presented as an example; other cancers in the context of comorbidity must be integrated. It is not known which diseases and other age-related health conditions are present at the time of a cancer diagnosis and to what extent the concomitant conditions compete for care and treatment, nor is there much information on how to treat cancer in the presence of pre-existing chronic conditions. Stronger ties need to be made between geriatric medicine and medical oncology to meet the current and future needs of the older age segment of the population. The demographic

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Cancer in Elderly People: Workshop Proceedings and epidemiologic data foretell the expanding U.S. population. The challenge is to understand the multiple clinical and quality care dimensions to meet what an aging population and potentially greater burden of cancer may impose on our health-care system as the number of older persons increases. Dr. William Robinson, Director, Office of Minority Health and Health Disparities, Health Resources and Services Administration: Dr. Yancik, your study of comorbidity started with age 55, and it looks as though you would have missed quite a bit of information if you had started with age 65. Dr. Yancik: Thank you for bringing that up. You recall my addressing the heterogeneity of age. In our study, we had a woman in the 55 to 64 age interval who had 10 comorbidities, and that shows that you may have uneven distribution of some of the age-related diseases. I tend to not use the word elderly unless I mean it. The demarcation point depends on what we address, but I try to use the terms older persons or older women. Dr. Robinson: My point is that we are looking at people in the second half of their lives, and if we were to somehow come up with a term that would pick that up, it might be helpful. We generally choose the 65 year mark because of historical Medicare and Social Security entitlements. Also, for a number of minority people, for people who tend to die a little bit earlier, we lose so many of them in the statistics if we stick with the older intervals. Dr Yancik: Agreed, often I say that 65 is arbitrary and was chosen because it is our entitlement age, but that was in the 1930s. As you saw from the life expectancy slide, 65 was considered very old in the first part of this century. So we are stuck with the 65 and older definition, but we always have to qualify it. I should mention that, in the breast cancer study’s case, the 55 to 64 interval was added as a comparison group, because this malignancy’s incidence tends to rapidly increase in the postmenopausal years. The other six tumors under study—colon, prostate, ovary, bladder, cervix, and stomach data—also include this comparison group. Dr. Thomas Burish, Provost, Notre Dame University: You have provided a great deal of descriptive data: for example, that cancer is a disease of

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Cancer in Elderly People: Workshop Proceedings In summary, then, we know there is a trend toward more aggressive cancer treatment in the elderly population, and we know that this is going to translate into a higher cost of caring for those patients. Studies need to be done to update earlier cost estimates to reflect technology advances because we know that just adjusting by inflation is not enough. We also need to reevaluate the disease burden and the cost-effectiveness of treatment to account for the unique physiologic characteristics of the elderly cancer population. We need to assess the effects of Medicare Part D and the Medicare Modernization Act on practice patterns, costs, and the disparities in financial burdens between high- and low-income cancer families. And finally, we need to examine strategies to address workforce shortages, such as using telemedicine or incentive programs to attract physicians to rural communities. Dr. Yancik: Thank you very much for that abundant information and a great talk, well delivered. I do not know if anybody else agrees, but what we are facing in terms of costs seems overwhelming. Dr. Foley: When ASCO studied physicians’ behaviors toward end-of-life care, they reported that they were not reimbursed to do it in an outpatient setting, and, therefore, did not do it. In discussing the proposed change in reimbursement for drugs, oncologists claimed that they had used the profits from drugs at average wholesale price to provide care for patients, to provide support. Now that drug profits have been reduced, they no longer will be able to provide that support, which will, in fact, affect their ability to care for complicated patients with complicated regimens, and, therefore, shift those patients back into a hospital setting. So I think it is all sort of a domino effect that could easily take place. Ann O’Mara, Program Director, Community Clinical Oncology Program, National Cancer Institute: Research Issues: I will be talking about what NCI is supporting regarding cancer in older persons in the extramural community. This means all the projects that are brought forward to the NCI for peer review, both investigator initiated and K awards. Also, I will discuss what the cooperative groups are doing in terms of the elderly population, because that is where a good amount of resources are. What we support responds to four overarching clinical problems: the underutilization of prevention strategies within the elderly cancer population; late diagnosis in that population; undertreatment; and, finally, defin-

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Cancer in Elderly People: Workshop Proceedings ing the older person—is that a 68-year-old who just ran the marathon yesterday or a 68-year-old with several comorbidities and a stroke? The definition is important to our cooperative groups and when accruing patients to our treatment trials when we specify patients must be age 65 or over. We are getting better at listing some of our comorbidities and refining that, but it still is quite a struggle. A search of the Computer Retrieval of Information on Scientific Projects (CRISP) public database of all funded projects for cancer in the older population yielded 19 relevant projects: 12 were investigator initiated, either RO1s, R21s, or the small RO3s; five were K mechanisms, specifically focused on developing a career in working with the older population, and two in the U mechanism, which were not cooperative groups but cooperative agreements. And there were seven different foci of these projects: four of them were focused on novel treatment or dosing schedules unique to the older population; four on prevention and screening, of which two were really comparing screening in cancer patients for cancer versus noncancer patients and screening for hypertension, diabetes, and so on. I am curious what the outcomes of those might have shown, whether we are screening better in the cancer population than in other chronic disease populations. Three projects focused on health services utilization; two on short- and long-term sequelae from cancer treatment; two on comorbidities; two on treatment utilization; and two on patient preferences and decision making about whether or not to take chemotherapy. When I examined how our investigators are going about pursuing these studies, I discovered, as you have previously heard, that most were secondary analyses employing the SEER-Medicare database. All four of the novel treatment or dosing schedules were clinical trials (and these were outside of the cooperative groups that I will cover later). The prevention and screening studies were secondary analyses (except for one or two that were prospective observational), as were all the health services utilization studies. There was one clinical trial focusing on ameliorating fatigue in cancer survivors over age 65 in the short- and long-term sequelae group, and the rest of the projects were either observational or secondary analyses. So that is the state of our current support of our investigator pool. I should caution you, however, that there are limitations to this search of CRISP, most notably that it yielded projects that were focused on the older population, and there may be many others that include older people in their particular trials. With respect to clinical trials and the cooperative groups, more than

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Cancer in Elderly People: Workshop Proceedings 50 percent of our adult cancer population is over 65, but only about 2.5 percent of our total U.S. adult cancer population accrue to NCI-supported trials, and less than one percent of the U.S. cancer population over 65 accrue to these NCI-supported trials. So the generalizability to older people of findings from our clinical trials is suspect at best. But, when I examined our disease treatment trials as well as our prevention and symptom management trials, I found some improvement. In our disease treatment trials, between 2001 and 2005, 30 percent of adult patients were over 65. Of these, over 80 percent were in the 65 to 70 group. Then, about 38 percent of our adult patients in prevention and symptom management trials were over age 65. So, that is somewhat reassuring. Nevertheless, the fact remains that we are only accruing about 2.5 percent of the adult population to our treatment trials. I should point out that the NCI has no information on industry-sponsored studies. We are not given information on the age of those patients unless we are also cosponsoring that study. And we do not collect information on institutional treatment trials at NCI-designated cancer centers. If you remember, our project enrollment is gender and ethnicity and race, not on age. So that is the information that we are collecting from our cancer centers. What are the barriers to enrolling elderly people? It goes back to how we define them, and it is related to our trial eligibility and how we list our comorbidities. We also have physician bias in terms of patients being eligible. Do they believe that they are eligible and appropriate for the trial? There is patient and family bias and myths that patients and families have about accruing to clinical trials. Social support that would encourage enrollment of the elderly cancer population in trials is a problem. Finally, what we know about referral patterns to cancer centers, as well as what we have learned about cancer within Medicare, suggests barriers to access to clinical trials. Currently, the NCI is sponsoring 12 cooperative group trials from phase 1 through phase 3, of which half are in acute myelogenous leukemia and the rest divided among lung (nonsmall cell), breast, brain, and genitourinary cancer. So, that summarizes where we are in cancer in the older population at the NCI through our R and K awards and where we are with our national clinical trials network, both from the Division of Cancer Treatment and more or less the Community Clinical Oncology Program of symptom management and prevention trials.

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Cancer in Elderly People: Workshop Proceedings Dr. Ganz: Did you look at the Institute for Nursing Research portfolio or perhaps the NIA? I just wondered if any might be hiding over there. Dr. O’Mara: That is a good question, and I did not. One could also look at the NIMH, because they do support some of these areas there. Dr. Ganz: But when we hear our portfolio analyses at the Board of Scientific Advisors and they want us to support a request for applications, they say 34 projects is low, and you have only 19. Dr. Yancik, Research Issues: I have worked in the NIA for 15 years. After 5 years in the NIA Office of the Director I had the opportunity to transfer into the extramural program to develop research on aging and cancer. I developed two program announcements immediately (1996), and then I convened a group of people to give me advice (1997). I am still working on the kinds of projects listed in Table 2-9. As you can see, coverage of our general areas of interest is broad. The NIA was established in 1974. In terms of its size and funding, probably it is midway within the spectrum of institutes. There was then and there is now much social concern about the aging population and a great deal of interest in health services for older persons that helped to build the NIA. A 1971 White House Conference on Aging spurred it on; there was a House Select Committee on Aging convened and chaired by Representative Claude D. Pepper. The programs of the institute include biology TABLE 2-9 NIA Priority Areas for Integration of Aging/Cancer Research Age-related factors in development of tumors in older persons Time and its importance in developing cancer in a person’s life span Aggressive tumor behavior in the aged patient Pharmacology of aging and cancer—antitumor drug alterations Prognostic indicators for patient evaluation and workup Comorbidity, previous illness, and disabilities in older cancer patients Occurrence of multiple primary tumors in the elderly Cancer survivorship—need long-term data on older cancer survivors Access issues for older patients, their families, and physicians Use generic age-related issues as in breast and prostate program announcements (PAs) SOURCE: Yancik, 1997b.

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Cancer in Elderly People: Workshop Proceedings of aging, behavioral and social science, neuroscience and neuropsychology, geriatrics and clinical gerontology, and the intramural program (Baltimore). The Geriatrics and Clinical Gerontology Program has research centers. They are called the Older American Independence Centers and are named after Representative Claude D. Pepper. Research topics include frailty prevention, menopause, health and longevity, osteoporosis and musculoskeletal disorders, falls prevention, geriatric syndromes, cardiovascular disorders, and cancer and aging. There are about 9–10 studies ongoing at any one time. They do not have to recompete every 5 years. The Cancer Research Initiatives that I initiated in conjunction with colleagues in other institutes include integrating aging and cancer research (R01s); aging, race, and ethnicity in prostate cancer; aging women and breast cancer; NCI clinical trials cooperative groups; studies on older patients; aging and risk factors for multiple primary tumors; cancer pharmacology and treatment in older patients; bioimaging techniques for early prostate cancer; long-term survivors research initiatives; interdisciplinary studies in genetic epidemiology of cancer; late medical effects of cancer treatment in older women; and diagnostic cancer imaging and radiation therapy in older patients. These have been issued as program announcements or requests for applications. Cancer pharmacology and treatment in older patients was the topic of a program announcement. Aging and risk factors for multiple primary tumors is one of my major interests. The NCI clinical trials cooperative groups studies on older cancer patients has generated the CALGB cancer clinical trial for older women and companion studies, as I mentioned. We have joined with the NCI for long-term survivors research initiatives. The interdisciplinary studies in genetic epidemiology and diagnostic cancer imaging and radiation therapy RFAs were initiated by the NCI; we joined as a dual assignment for some grants. We achieved a major goal by issuing the aging, race, and ethnicity in prostate cancer RFA. To examine the pharmacology of aging and cancer the NCI is pursuing studies on dosage, administration, and special monitoring needs of older persons with cancer; treatment considerations factoring in changes in body composition and organ function, drug tolerance, and drug-drug interaction; relationship of drug interventions or combination therapies as they occur in combination with age-associated comorbidities (and in comorbid disease-free patients); and interaction with older persons’ own use of medications and other prescribed and over-the-counter medications. The relationship of drug interventions or combination therapies as

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Cancer in Elderly People: Workshop Proceedings they occur in combination with age-associated comorbidities is very important. Comorbidity and the influence of frailty on the course of cancer patient management are so important for the early detection of primary cancer or recurrence. The NIA and the NCI held a large workshop to explore the role of NCI-designated cancer centers for integrating aging and cancer research in 2001. We convened plenary sessions and seven working groups for 2 1/2 days. We had approximately 120 participants. I worked with the cancer center branch staff in putting together the initiative under which eight cancer centers received awards in August 2003. This a $26-million project shared equally by the NCI and the NIA. I would like to share the NIA/NCI workshop report with you. It can be found at http://www.nia.nih.gov/ResearchInformation/ConferencesandMeetings/WorkshopReport. Thanks for the opportunity to present these aging and cancer research efforts that have developed. Dr. Jerome Yates, Research Issues: I am going to talk both about the American Cancer Society (ACS) research program and a little bit about our advocacy efforts, things that we can do to try to enhance progress. There are activities inside of the ACS that are not directly related to research activities. We have health promotions that are largely public education and other efforts involving our collaboration with the NCI. We are funding one of the navigator research sites, and we are also funding the training and the evaluation for the NCI-supported navigator activities. We think that, in the end, this will help us optimize our programs and also enhance our relationships with the NCI. We do a great deal of public education, and we target that to some extent. We operate our National Cancer Information Center, a 24-hour, 7-day a week telephone access cancer help line. On the epidemiological front, the ACS annual Cancer Facts and Figures publication is widely used. The cohort studies (Cancer Prevention Studies 1 and 2–CPS-1 and 2) have looked at tobacco smoking and cancer in the past and cancer and obesity more recently. There is another study in the works, CPS-3, that will be an epidemiological (prospective cohort) study that will involve collecting biologic materials and seek to better understand the relationships among lifestyle and behavioral, environmental, and genetic factors that cause or prevent cancer. Our Behavioral Research Center is largely focused on survivor and patient care studies now, but it will be looking at provider and patient decision making in the future.

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Cancer in Elderly People: Workshop Proceedings From 1998 to 2007, we have funded eight training grants at the masters of science (M.S.) and doctorate (Ph.D.) levels, eight basic science laboratory grants, two screening grants for colorectal cancer, two on comorbidity, two on cancer care, one on pain management, and one on quality of life in lymphoma at a total of $7,526,000. The M.S. and Ph.D. training grants are for nurses and social workers. The basic science grants are related to aging studies at the cellular or basic level. Our advocacy activities are going to focus a great deal on access to health care, both the legislation, it is hoped, for universal health care and how the regulations are written. We have been trying to get the CMS to perform a chronic disease, cancerlike demonstration project, and I think that some coordinated effort from a variety of organizations might, in fact, help that to come about. In the targeted research area, although this is not elderly research, we have set aside $500,000 for pilot projects for palliative care research. This is largely to generate data so that people will have enough information to submit RO1s. We received 130 applications for this; there is a great deal of interest out there. We also set aside $1 million for health policy research, which is going to be focused, we think, in areas that are relevant to the mission of the ACS. We have formed a coalition with the heart and diabetes associations to look specifically at obesity and exercise activities and generally at disease prevention. Needless to say, we are part of a large group of organizations that are trying to get more funding for the NIH. We have already talked about the changing demographics today. Here we need more public education (including caregivers) and I think some social solutions. National data showed in 1995 that 46 percent of women over 65 were widowed. There clearly will be many widows in the coming decades. The living arrangements are such that men are living with their wives, and widows are living alone or with nonfamily. Social support for those that are living alone will be needed, as many have limited social activity and insecurity about any source of assistance if needed. And they have greater levels of depression, poor adjustment to illness, and increased relative risk of mortality if they are isolated compared to those with support. The economics are not reassuring. In 2006, there will be five workers for each retiree and Medicare will be 8 percent of GDP. In 2030, there will be three workers per retiree and Medicare is projected at 13 percent of GDP. It certainly looks as though we are going to have some big problems in terms of how we finance these programs. Now, I would like to briefly touch on the Value of Health and Longev-

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Cancer in Elderly People: Workshop Proceedings ity study and what that tells us about looking at the economics of these issues (Murphy and Topel, 2006). We have already been addressing the productivity issues, and there are many studies looking at the cost of care at the end of life. This study examined the dollars that are spent for different age groups; it considered the individuals’ willingness to pay to maintain health and used the values ascribed to that willingness to assign values to health improvements. From 1970 to 2000, improved life expectancy added $3.2 trillion per year to national wealth (or about half of GDP), and a permanent 1 percent reduction in mortality from cancer was calculated to have a value of $500 billion. This was not the result of increased productivity from avoidable mortality. For individuals, significant personal values were calculated for a 10 percent reduction in cancer mortality at all ages even including into the 70s and 80s. The social value of health improvements will improve with increased population growth, increased capital incomes (unless there are cuts in social programs), and increased growth in the component for the older population even with medical conditions. There have been a couple of studies lately that have highlighted the fact that the common cancers in elderly people are heterogeneous and that we are not likely to have single specific treatments for them as we do for chronic myelocytic leukemia or gastrointestinal stromal tumors. That emphasizes the importance of detecting the disease early and treating patients with surgery to the extent that we can. There may at some point be tests such as the PSA or the like that will help with that. A recent Agency for Healthcare Research and Quality (AHRQ) report noted the great increase in lumpectomies for treatment of breast cancer. Because half of breast cancer is in elderly people, these older women will be receiving treatment in the outpatient setting and then will be going home. At that point, someone will have to care for them, and the education to do this is not in place. One can only imagine some of the problems that occur as a result of this deficit. So where should we go in the future? I think we need to have better early detection programs. We need to be able to categorize comorbidities with some consistency. Palliative care is clearly important. Individuals are going to need to be liberated from institutions, hospitals, and nursing homes, but if we do that we need the support systems in place to take care of these individuals when they are outside of these institutions. And there has to be a better way of monitoring the quality of care in these situations. At the moment, there is no infrastructure to do this. So we need some changes in health policy. We need to think about the caregivers; we need to

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Cancer in Elderly People: Workshop Proceedings be able to train them and provide them with adequate backup and support. We need incentives for families to take care of the patient, so all of this is not just out-of-pocket care, and the ACS will think about modifying some of its traditional supportive programs, such as Reach to Recovery, to try to fill some of these niches. Dr. Ganz: Just to that last point, in California, because of the managed care situation, we have been seeing mostly outpatient procedures for a long time. I have been seeing women who have never had any education about lymphedema-protective activities. They had not been given any guidance or counseling. In the old days, when they were in the hospital for 5 to 7 days, and there was not much going on, the nurses did a great deal of education, and the Reach to Recovery volunteer came by. So what has happened? I think there is such a void there now that there is a real need for your types of programs. Dr. Yates: Yes, we need to restructure the Reach to Recovery Program. We ought to be talking about different kinds of messages. Formerly, there was a fair amount of physical therapy along with psychosocial support. Now there is some psychosocial support, but we really could be conveying better educational messages, and I think that is what we need to think about doing. Dr Ferrell: The American Cancer Society could make a great contribution by creating a “preparing to care for someone you love with cancer” program, where family members could come in and learn about caring throughout the whole trajectory of cancer care. Dr. Yates: We are developing a curriculum for the Navigator Program that addresses helping people, understanding what questions to ask, and what needs to be emphasized. We could address caregiving in cancer in a similar way and try to develop a curriculum to address the important issues. I hope I could call on some of you to participate in that activity. Ms. Boyle: I think there are programs that are trying to do it. The problem is they do not publish, but if there was a way to have a workshop to look at best practices, some of those who have tried educational interventions could describe their work. I know in Australia, there is a large breast care nurse contingent within oncology nursing; it would be interesting to see their curriculum.

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Cancer in Elderly People: Workshop Proceedings Dr. Yates: Agreed, although they have socialized medicine, and that makes it much easier to incorporate these things into the health-care system. Dr. Matrisian: On the research side, the NCI/NIA joint centers seem a sensible idea. So, three years in, how are they working? Dr. Yancik: The rationale behind the initiative was to give enough resources to the grantees so they could build an aging and cancer component into their core grant or its equivalent and ultimately obtain continued funding. They have just entered their fourth year. The last two annual meetings have been extremely useful with good attendance, including both the NCI and NIA directors. Those involved feel they are all under one roof as part of the group. Yes, it remains to be seen whether or not they will all be successful, but everybody seems to be working as hard as they can and are involved in generating research support in the crosscutting areas they selected. Dr. Foley: We did not talk today about how the Centers for Disease Control and Prevention (CDC), with the state plans, are addressing this issue. And the most marginalized populations that would be effected by this are clearly those who do not have access, and that would be our minority populations. We did not talk about Native Americans. We did not talk about African Americans in any great detail, and then there is a prison population who are aging and have cancer. So, there are three disparity populations that I think need some coverage on this issue, who get marginalized to begin with, and then, if they are elderly, get even more marginalized in the health care system. We should also think about our illegal immigrants. Mr. Kean: I learned a great deal today that was very helpful to me. At the end of November, the National Partners for Comprehensive Cancer Control are convening to talk about phase 4 of the leadership institutes and state plan implementation that begins in early 2007, and I made a number of notes today on things that ought to be considered. I will carry the message back about some of the issues you put on the table today. Dr. Yates: One of the problems about the state cancer plans, as you know, is most of them did not get funded. But the ACS will use the report card for the states, have the divisions support better pain management in those respective states, and use their clout to try to change legislation and regulations in the individual states.

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Cancer in Elderly People: Workshop Proceedings In terms of disparities, the Navigator Program was actually designed to address the disparity issue, and, using unpublished data from the American College of Surgeons National Cancer Database, Elizabeth Ward has compared educational levels of cancer patients with survival data and found that mortality is inversely related to education level. Education level is more important than income in terms of determining survival, and this is not just true for cancer. We think the Navigator Program will help these people navigate the system better than they would if they were alone. We also are looking at establishing a national vice president for disparities, because one of the internal complaints that we have had is that, although we talk about doing something about disparities, we have not done a great deal so far. Ms. Boyle: In terms of the earlier comment about culture, I just tried to review the literature on breast and prostate cancer specific to African Americans in getting ready to do a talk in South Carolina, and there is very little. So it is another area where there is a big question mark. Dr. Robinson: There is a website by the Office of Minority Health Resource Center, HtmlResAnchor www.omhrc.gov, that has information from the different racial and ethnic groups on different health topics, including cancer, with statistics on various cancers in the major racial and ethnic minority groups. I do not recall specifically if there is detail about age groups. Dr. Silliman: The age structure of many of these minority populations, such as Hispanics, is younger. Only about five percent of older breast cancer patients with early-stage disease are African American, and this sort of thing makes the numbers problematic for studies in one geographic location. So you need to have integrated health systems or take advantage of SEER-Medicare data. Those are some of the challenges, not to say it is not really important. In integrated health plans such as Kaiser where people have uniform coverage, the disparities are nonexistent. Dr. Moses: Concluding Remarks and Adjourn: I would like to thank all the speakers and the discussants. It has been a good day, and when it is written up I think it will make a good report. Many thanks to all of you.